Devices and methods useable for treatment of glaucoma and other surgical procedures

ABSTRACT

A device and method for cutting or ablating tissue in a human or veterinary patient includes an elongate probe having a distal end, a tissue cutting or ablating apparatus located adjacent within the distal end, and a tissue protector extending from the distal end. The protector generally has a first side and a second side and the tissue cutting or ablating apparatus is located adjacent to the first side thereof. The distal end is structured to be 0 into tissue or otherwise placed and positioned within the patient&#39;s body such that tissue adjacent to the first side of the protector is cut away or ablated by the tissue cutting or ablation apparatus while tissue that is adjacent to the second side of the protector is not substantially damaged by the tissue cutting or ablating apparatus.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/923,302 filed Oct. 26, 2015 and issuing as U.S. Pat. No. 10,123,905on Nov. 13, 2018, which is a division of U.S. patent application Ser.No. 10/560,266 filed May 11, 2006 and now abandoned, which was a 35U.S.C. § 371 national stage of PCT International Patent Application No.PCT/US2004/018483 filed Jun. 10, 2004, which claims priority to U.S.Provisional Patent Application No. 60/477,258 filed Jun. 10, 2003, theentire disclosure of each such application being expressly incorporatedherein by reference.

BACKGROUND OF THE INVENTION

A. Symptoms and Etiology of Glaucoma

The term “glaucoma” refers generally to a group of diseases which causeprogressive damage to the optic nerve and resultant optical fielddefects, vision loss and, in some cases, blindness. Glaucoma isfrequently, but not always, accompanied by abnormally high intraocularpressure. Aqueous humor is continually produced by cells of the ciliarybody and such aqueous humor fills the anterior chamber of the eye.Excess aqueous humor normally drains from the anterior chamber of theeye, through a structure known as the trabecular meshwork and then outof the eye through a series of drainage tubules. However, in manyglaucoma patients, drainage of the aqueous humor through the trabecularmeshwork is impaired, thereby causing the pressure of aqueous humorwithin the anterior chamber to increase.

In general, there are four types of glaucoma—primary, secondary,congenital and pigmentary. Primary glaucoma, which is the most commonform, can be classified as either open angle or closed angle. Secondaryglaucoma (e.g., neovascular glaucoma) occurs as a complication of avariety of other conditions, such as injury, inflammation, vasculardisease and diabetes. Congenital glaucoma is elevated eye pressurepresent at birth due to a developmental defect in the eye's drainagemechanism. Pigmentary glaucoma is a rare form of the disease whereinpigment from the iris clogs the trabecular meshwork, preventing thedrainage of aqueous humor from the anterior chamber.

Glaucoma is a leading cause of blindness in the United States. The lossof vision in glaucoma patients is typically progressive and may be due,at least in part, to compression of the vasculature of the retina andoptic nerve as a result of increased intraocular pressure. It isgenerally accepted that reducing intraocular pressure, through the useof drugs and/or surgery, can significantly reduce glaucomatousprogression in patients who suffer from normal-tension glaucoma and canvirtually halt glaucomatous progression in patients who suffer fromprimary open-angle glaucoma with elevated intraocular pressures.Furthermore, it is generally acknowledged that lowering intraocularpressure in glaucoma patients can prevent or lessen the irreversibleglaucoma-associated destruction of optic nerve fibers and the resultantirreversible vision loss.

B. Surgical Treatment of Glaucoma

The surgical treatment of glaucoma is generally aimed at either a)decreasing the amount of aqueous humor produced by the ciliary body orb) improving drainage of aqueous humor from the anterior chamber of theeye.

The procedures aimed at decreasing the production of aqueous humorinclude cyclocryotherapy, wherein a cryosurgical probe is used to freezea portion of the ciliary body, thereby destroying cells that produceaqueous humor, and laser cyclophotocoagulation, wherein a laser is usedto destroy part of the ciliary body resulting in decreased production ofaqueous humor.

The procedures intended to improve drainage of aqueous humor from theanterior chamber include trabeculoplasty, trabeculectomy, goniectomy andshunt implantation.

In trabeculoplasty, the surgeon uses a laser to create small holesthrough the trabecular meshwork to increase aqueous humor drainagethrough the normal drainage channels.

In trabeculectomy, the surgeon removes a tiny piece of the wall of theeye, which may include a portion of the trabecular meshwork, therebycreating a new drainage channel which bypasses the trabecular meshworkand the normal drainage channels. Aqueous humor then drains withrelative ease through the new drainage channel into a reservoir known asa “bleb” that has been created underneath the conjunctiva. Aqueous humorthat drains into the bleb is then absorbed by the body. Trabeculectomyis often used in patients who have been unsuccessfully treated withtrabeculoplasty or who suffer from advanced glaucoma where optic nervedamage is progressing and intraocular pressure is significantlyelevated.

In goniectomy, a tissue cutting or ablating device is inserted into theanterior chamber of the eye and used to remove a full thickness strip ofthe tissue from the trabecular meshwork overlying Schlemm's canal. Inmany cases, a strip of about 2 mm to about 10 mm in length and about 50μm to about 200 μm in width is removed. This creates a permanent openingin the trabecular meshwork through which aqueous humor may drain. Thegoniectomy procedure and certain prior art instruments useable toperform such procedure are described in U.S. patent application Ser. No.10/052,473 published as No. 2002/0111608A1 (Baerveldt), the entirety ofwhich is expressly incorporated herein by reference.

In shunt implantation procedures, a small drainage tube or shunt isimplanted in the eye such that aqueous humor may drain from the anteriorchamber, through the shunt and into a surgically createdsub-conjunctival pocket or “bleb.” Aqueous humor that drains into thebleb is then absorbed by the patient's body.

Trabeculoplasty, trabeculectomy and shunt implantation procedures aresometimes unsuccessful due to scarring of closure of the surgicallycreated channels or holes and/or clogging of the drainage tube. Becauseit involves removal of a full thickness strip from the trabecularmeshwork, the goniectomy procedure is less likely to fail due toscarring or natural closure of the surgically created channel. Althoughthe previously described devices can be used to successfully performgoniectomy procedures, there remains a need in the art for thedevelopment of new tissue cutting and ablation instruments that may beused to perform the goniectomy procedure as well as other procedureswhere it is desired to remove a strip of tissue from the body of a humanor veterinary patient.

SUMMARY OF THE INVENTION

The present invention provides a device for cutting or ablating tissuein a human or veterinary patient. This device generally comprises,consists essentially of, or consists of: a) an elongate probe having adistal end, b) a tissue cutting or ablating apparatus and c) a protectorthat extends from the probe. The protector generally has a first sideand a second side and the tissue cutting or ablating apparatus islocated adjacent to the first side of the protector. The distal end ofthe probe having protector extending therefrom, is structured to beadvanceable into tissue or otherwise placed and positioned within thepatient's body such that tissue adjacent to the first side of theprotector is cut away or ablated by the tissue cutting or ablationapparatus while tissue that is adjacent to the second side of theprotector is not substantially damaged by the tissue cutting or ablatingapparatus.

Additionally, the protector may be formed entirely or partially of aninsulating material. For example, the protector may be formed of a coremade of an electrically and/or thermally conductive material, forexample a conductive metallic material, and may include a non-conductivecoating or covering, for example a polymer coating that is electricallyand thermally insulating. In some embodiments of the invention, theelectrically and thermally insulating material, hereinafter sometimessimply referred to as “coating” may comprise a flexible, pliablematerial in comparison with the more rigid core.

In some embodiments of the invention, the protector is configured notonly to provide protection to tissue located adjacent to the second sideof the protector, but also may be configured to facilitate positioningand/or advancement of the device within the surgical site. In thisparticular regard, above-incorporated United States Patent ApplicationNo. 2002/0111608A1 (Baerveldt) describes goniectomy devices that have afoot plate sized and configured to be inserted through the trabecularmeshwork and into Schlemm's Canal and to, thereafter, advance throughSchlemm's Canal as the device is used to remove a portion of thetrabecular meshwork. In embodiments of the present invention that areused to remove portions of the trabecular meshwork (i.e., to perform agoniectomy procedure) the protector may be configured, for exampleshaped and sized, for insertion and advancement through Schlemm's Canalin substantially the same manner as that described in theabove-incorporated United States Patent Application No. 2002/0111608A1(Baerveldt).

It is to be appreciated that in embodiments of the device of the presentinvention that are designed and/or intended for use in tissue cutting orablating applications other than goniectomy procedures, the protectormay be of any other suitable configuration required to perform thedesired protection and/or positioning/guidance functions.

The tissue cutting or ablating apparatus may comprise any suitable typeof apparatus that is operative to cut or ablate tissue, for example astrip of tissue. For example, the cutting and ablating apparatus maycomprise a electrosurgical or radiofrequency tissue cutting or ablationapparatus (e.g., monopolar or bipolar configured electrodes), apparatus(e.g., a light guide and/or lens) that emits light energy to causethermal cutting or ablation of tissue (e.g., pulsed or non-pulsedoptical incoherent high intensity light, pulsed or non-pulsed laserlight, light that is infrared, visible an for ultraviolet, etc.),mechanical tissue cutting or ablation apparatus (e.g., knife blade(s),scissor(s), rotating cutter(s), etc.), ultrasonic cutting or ablationapparatus (e.g., an ultrasound transmission member that extends throughthe device to a location adjacent the first side of the protector andundergoes axial or radial ultrasonic vibration), or any other suitablemechanism. In embodiments where the cutting or ablating apparatuscomprises knife blade(s), an implementation may be based on a pluralityof knife edges so that a stripe of tissue may be dissected and madeavailable for removal.

Optionally, the device may further include one or more lumen(s) forproviding fluid infusion and/or aspiration to and/or from the surgicalsite, for example from a remote infusion and/or aspiration source.

In some embodiments of the invention, the device is in the form of anelongate probe that is attachable to a surgical handpiece forfacilitating manual manipulation of the probe. In some embodiments ofthe invention, the entire device is structured and intended for one timeuse, and in other embodiments of the invention, one or more componentsof the device are autoclavable and reusable. For example, in someembodiments of the invention, the device comprises a disposable catheterprobe having a molded distal end including the protector and/or thecutting or ablating apparatus integrally molded or formed in the distalend of the catheter. In other embodiments of the invention, the deviceincludes a elongate probe, made of one or more segments of stainlesssteel hypotubing, and including a proximal portion that is configured tobe received within a conventional surgical handpiece, which may includevarious functionable switches, conduit ports, electrical connections andthe like for enabling manual operation of the various functions of thedevice to be described elsewhere herein.

For example, the present device may be configured and structured to becouplable to 1) a console, for example, a control console, or otherseparate apparatus having for example, but not limited to anelectosurgical signal generator for transmitting energy needed tooperate the tissue cutting or ablation apparatus, for example anelectosurgical signal generator suitable for providing electrical energyto the cutting or ablating apparatus utilizing incoherent or laser lightenergy, such as infrared, visible, and/or ultraviolet wave energy,rotating shaft or other mechanical drive, etc., and/or 2) an aspirationsource, for example comprising a pump mechanism for aspirating fluidfrom the surgical site through the optional aspiration lumen (ifpresent) of the device and/or 3) a source of fluid, for example anirrigation source, for infusing or irrigating the surgical site throughthe optional fluid infusion lumen (if present) of the device. Examplesof commercially available surgical consoles that may be suitable for usewith the present invention, for example, surgical consoles of which thepresent devices may be attached or connected to, include but are notlimited to the Infinity/Accurus/Legacy Systems, available from Alcon,Inc., Fort Worth, Tex., the Millinium System, available from the Bausch& Lomb Corporation, Rochester, N.Y., or the Sovereign System, availablefrom Advanced Medical Optics, Santa Ana, Calif.

Further in accordance with the invention, some embodiments of the devicemay be constructed to cut and remove a strip or pieces of tissue fromthe patient's body and to permit retrieval of that strip or pieces oftissue to prevent them from causing untoward postsurgical effects withinthe body or for preservation, biopsy, chemical/biological analysis orother purposes. In embodiments of the device that are equipped with theoptional aspiration lumen, the aspiration lumen may be positioned suchthat a strip or pieces of tissue cut or severed by the tissue cutting orablation apparatus may be withdrawn from the body through the aspirationlumen.

Still further in accordance with the invention, the width or size of thetissue that is cut or ablated from the patient's body, as well as thedegree to which adjacent tissues that remain in the body are damaged bythermal energy or other affects of the cutting or ablation process, maybe controlled in some embodiments of the device by controlling theamount of power or energy that is delivered to the tissue cutting orablation apparatus. In this regard, in embodiments where the tissuecutting or ablation apparatus is a monopolar or bipolar electrosurgicalapparatus, there will be a high power density zone closest to theelectrode(s) wherein thermal cutting or ablation of tissue will occur.This high power density zone may be surrounded by a medium power densityzone wherein the thermal energy is great enough to also cut or ablatetissue under some circumstances. The voltage and/or current supplied tothe electrode(s) may be adjusted to control the size and extent of thehigh power density zone and/or the surrounding medium power densityzone, thereby providing for cutting or ablation of a strip of tissue ofa desired size while avoiding significant or irreparable damage totissue that is to be protected (e.g., tissue located on the second sideof the protector) or other tissue at the margins of or in closeproximity to the strip of tissue that has been cut or ablated.

Still further in accordance with the invention there are providedmethods for performing medical or surgical procedures, includingpercutaneous surgical procedures, using the devices of the presentinvention. For example, the present invention provides method forperforming a goniectomy procedure, wherein the protector of the device,for example the device of the present invention described elsewhereherein, is inserted through the trabecular meshwork into Schlemm'sCanal, and the tissue cutting or ablating apparatus is energized and thedevice is advanced in a manner that results in cutting or ablation of aportion of the trabecular meshwork. In a general tissue cuttingprocedure, the protector of the device is inserted to a desiredposition, the tissue cutting or ablation device is energized and thedevice is advanced, thereby causing a strip to be cut or ablated fromtissue that becomes positioned on the first side of the protector whileno substantial damage occurs to tissue located on the second side of theprotector.

Further in accordance with the invention, some embodiments of the devicemay be fabricated in part from tubing, such as stainless steelhypotubing (referred to as “tube-fabricated” embodiments. In suchtube-fabricated embodiments, the device generally comprises an outertube and an inner tube, wherein the inner tube extends through the lumenof the outer tube and a distal portion of the inner tube extends out ofand beyond the distal end of the outer tube. The protector is formed onthe distal end of the inner tube and the tissue cutting or ablationapparatus may be formed on and/or inserted through the inner tube suchthat it is positioned at a location adjacent to the first side of theprotector. Also, the lumens of the inner and/or outer tubes may be usedfor infusion and/or aspiration of fluid.

Still further in accordance with the invention, there is provided amethod for manufacturing the tube-fabricated embodiments of the device.Such method generally comprises A) providing an inner tube and an outertube and inserting the inner tube through the lumen of the outer tubesuch that a distal portion of the inner tube extends out of and beyondthe distal end of the outer tube, B) forming cuts in the distal portionof the inner tube to form at least one leg thereon, C) bending a legformed in Step B to create a protector having a first side and a secondside and D) positioning the tissue cutting or ablation apparatusadjacent to the first side of the protector. Optionally, in someembodiments, the method may further comprise the step of E) applying aninsulating material (e.g., a polymer such as polyimide) to theprotector. Such insulating material may be applied to the protector byany suitable method, such as by single layer dip coating, multiple layerdip coating, spray coating, painting, electrostatic powder deposition,vapor deposition, advancement of a fabricated insulating cover over theprotector, etc.

Still further in accordance with the invention, in manufacturing sometube-fabricated embodiments wherein the tissue cutting or ablationapparatus comprises an electrosurgical apparatus, an electrode may beformed by additionally cutting and bending a part of the distal portionof the inner tube to form such electrode. In this regard, Step B of theabove-summarized manufacturing method may comprise cutting the distalportion of the inner tube to create first and second legs thereon and,thereafter, Step C of the above-summarized manufacturing method maycomprise i) bending the first leg to create a protector having a firstside and a second side and ii) bending the second leg to create anelectrode adjacent to the first side of the protector. Electrical energymay then be transmitted through the inner tube to the electrode formedon its distal portion. In embodiments where the electrosurgicalapparatus is monopolar, only one electrode need be formed adjacent tothe first side of the protector and an exposed or capacitively coupledgrounding electrode may be attached to the patient's body near the siteof the surgery or elsewhere on the body. In embodiments where theelectrosurgical apparatus is bipolar, it will be necessary to locate asecond electrode adjacent to the first side of the protector. Suchsecond electrode may be so positioned by advancing an electricalconduction member that has an electrode surface on its distal end (e.g.,an insulated wire having the insulation removed from its distal tip)through the lumen of the inner tube to a position where the electrodesurface of the electrical conduction member is located adjacent to thefirst side of the protector and a desired distance from the otherelectrode. The electrical conduction member/second electrode may besecured in place by adhesive, mechanical constraint or any othersuitable affixation means. In this regard, aperture(s) may be formed inone or both of the leg(s) formed in Step B and the electricallyconductive member may extend through such aperture(s) such that theaperture(s) will localize, guide the positioning of, hold, stabilize oraffix the location of the electrical conducting member/second electrode.

Further aspects and elements of the invention will be understood bythose of skill in the art upon reading the detailed description ofspecific examples set forth herebelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a system incorporating anelectrosurgical goniectomy device of the present invention.

FIG. 2 is an enlarged perspective view of section 2 of FIG. 1.

FIGS. 3A-3G and 3A'-3F' are step-by-step showings of an example of amethod for manufacturing an electrosurgical goniectomy device of thepresent invention.

FIG. 4A is a cross section of a human eye having electrosurgicalgoniectomy device inserted thereinto.

FIG. 4B is an enlarged view of a portion of the human eye showing theangle, Schlemm's Canal and the trabecular meshwork.

FIG. 4C is an enlarged view of a distal portion of the device being usedto remove trabecular meshwork tissue from an eye during a goniectomyprocedure.

FIG. 5A is a perspective view of a distal portion of anotherelectrosurgical goniectomy device of the present invention.

FIG. 5B is a side view of the distal end of the electrosurgicalgoniectomy device of FIG. 5A.

DETAILED DESCRIPTION

Turning now to FIG. 1, a device in accordance with the present inventionfor cutting and/or ablating tissue, for example, tissue of an eye duringa goniectomy procedure, is shown generally at 10. The device 10generally comprises an elongate handpiece or probe having a distal endhaving a tissue cutting or ablating apparatus 4 disposed generallywithin the distal end or distal portion of the probe 3. The tissuecutting or ablating apparatus 4 may be a suitable mechanism designed tocut, ablate, cauterize, sever and/or remove tissue from a target region,for example, from a surgical site. The device 10 may be part of a largersurgical system 11, for example, the device 10 may be structured andadapted to be operatively connectable to a separate apparatus, forexample a surgical control console 70 for controlling and poweringoperation of various functions of the device during a surgicalprocedure. Examples of surgical consoles that may be suitable includebut are not limited to the Infinity/Accurus/Legacy Systems, availablefrom Alcon, Inc., Fort Worth, Tex., the Millinium System, available fromthe Bausch & Lomb Corporation, Rochester, N.Y., or the Sovereign System,available from Advanced Medical Optics, Santa Ana, Calif.

A distal end of a tube-fabricated embodiment of the device 10 is shownin FIG. 2. This particular device 10 is designed to be especiallyeffective for cutting/ablating and sometimes removing tissue, forexample portions of the trabecular meshwork during a goniectomyprocedure. It should be appreciated that although the followingdescription will generally refer to this specific embodiment, the scopeof the present invention is not intended to be limited thereby. Forexample, the device 10 may be modified as necessary and/or desirable tobe effective for use in surgical procedures other than goniectomyprocedures and such modified devices are considered to be within thescope of the present invention.

The tube-fabricated device 10 generally comprises a probe 3 comprisingan outer tube 12 and an inner tube 14 disposed therein and having adistal portion extending or projecting therefrom.

As shown in FIG. 2, the inner tube 14 has a smaller outer diameter thanan inner diameter of the outer tube 12 such that when inner tube 14 ispositioned within the outer tube 12, for example, substantially coaxialtherewith, the outer tube 12 inner surface is spaced apart from theinner tube 14 outer surface as shown.

More specifically, the outer tube 12 defines a lumen 16 which may serveas an infusion lumen, hereinafter sometime referred to as an irrigationlumen. For example, the outer tube 12 may include an irrigation orinfusion port 26 disposed on the distal portion of the outer tube 12 asshown. During a surgical procedure, irrigation fluid, such as a balancedsalt solution (BSS) may be passed through lumen 16 and out of port 26and into the anterior chamber of an eye as needed to maintain a desiredintraocular pressure in the eye.

The inner tube 14 generally contains or defines the cutting or ablatingportion of the device 10, as will be described in greater detailelsewhere herein. The inner tube 14 also defines a lumen 19, preferablyhaving a port adjacent the cutting or ablating apparatus, wherein thelumen 19 may serve as an aspiration lumen during the surgical procedure.Accordingly, an aspiration source may be connected to inner tube lumen19 to allow cut tissue, excess fluid or other material to be suctionedor removed from the surgical site during the procedure.

In embodiments of the device that are designed for cutting or ablatingtissue during a goniectomy procedure, the device 10 is preferably sizedand configured such that the distal end thereof can be placed within aneye, for example within the anterior chamber of the eye, as far as andincluding the irrigation port 26. It is noted that irrigation port 26may alternatively be utilized as an aspiration port in somecircumstances, if desirable.

It is further contemplated that in some instances it may be helpful toutilize the aspiration lumen 19 as a temporary or even permanentirrigation lumen such that irrigation fluid is passed from the distalopening of the inner tube 14. For example, as the device 10 is initiallybeing inserted into the anterior chamber prior to the cutting orablation of tissue, it may be helpful to pass irrigation fluid into theanterior chamber of the eye through the inner tube 14 in order tomaintain ocular pressure and facilitate further insertion of the distalend of the relatively wider outer tube 12 of the device 10. Once thedistal end of the outer tube 12 is in place in the anterior chamber asufficiently distance such that port 26 is located within the anteriorchamber, irrigation of the eye may be moved to the outer tube irrigationport 26. Initial irrigation by means of the inner lumen 19 may also behelpful in causing gentle widening of the insertion site so as to moreeasily allow insertion of the relatively wider outer tube through theinsertion site.

Preferably, all components of the device 10 are comprised of surgicalgrade materials. In addition, with the exception of the cutting orablating surfaces of the device 10, exposed surfaces of the distal endof the device are preferably formed and/or treated such that theyinclude substantially no sharp portions, burrs or contaminants. Forexample, in the embodiment shown in FIG. 2, the distal most portion ofthe outer tube 12 is rounded or frustro-conical in shape, so as toprevent or reduce the occurrence of any substantial damage to tissueupon insertion, operation and removal of the device 10 from the eye.

For devices of the invention designed for goniectomy surgicalprocedures, the outer tube 12 may comprise about 19 gauge to about 20gauge stainless steel hypotubing, and the inner tube 14 may compriseabout 25 gauge stainless steel hypotubing. In addition, preferably forsuch devices of the invention, the projecting distal portion of theinner tube 14 has a length L of between about 1 mm and about 4 mm, andmore preferably about 2.5 mm.

The cutting or ablating portion of the device 10 may comprise anysuitable mechanism for cutting or ablating tissue. For example, in thespecific embodiment shown in FIG. 2, the cutting or ablating apparatuscomprises an electrosurgical tissue cutting/ablating apparatus. Morespecifically, the device 10 includes a bipolar electrode mechanismcomprising a first pole or first electrode 22 and a second pole orsecond electrode 21. In use, one of the first and second electrodes isprovided with electrical energy and to operate as an active electrodeand the other of the first and second electrodes operates as a returnelectrode. When such an electrode is powered it generates a zone of highenergy in immediate proximity of the electrode, and a zone of relativelylower energy outside of the zone of high energy. This zone of relativelylower energy is a zone of thermal energy that is effective in cutting orablating ocular tissue, for instance, particularly tissue of thetrabecular meshwork. The return electrode may be electrically couplableto the patient's body.

It is contemplated that alternative embodiments of the invention mayinclude any other suitable mechanism or apparatus that is operative tocut or ablate tissue, for example a strip of tissue, such as a monopolarelectrode mechanism, a radiofrequency tissue cutting or ablationapparatus, apparatus (e.g., a light guide and/or lens) that emits lightenergy to cause thermal cutting or ablation of tissue (e.g., pulsed ornon-pulsed optical incoherent high intensity light, pulsed or non-pulsedlaser light, light that is infrared, visible and/or ultraviolet, etc.),mechanical tissue cutting or ablation apparatus (e.g., knife blade(s),scissor(s), rotating cutter(s), etc.), ultrasonic cutting or ablationapparatus (e.g., an ultrasound transmission member that extends throughthe device to a location adjacent the first side of the protector andundergoes axial or radial ultrasonic vibration) or others.

The device 10 further comprises a protector 24 having a first sidelocated adjacent to the cutting or ablating apparatus, and a second sidelocated on a distal-most portion of the device 10. The protector 24 isstructured and designed to preventing damage to tissue located near thetissue to be cut. For example, the protector 24 is designed to protector prevent any substantial damage to surfaces of Schlemm's canal whilethe device 10 is being utilized to cut portions of the trabecularmeshwork during a goniectomy procedure.

More particularly, the device 10 may be structured such that the tissuecutting or ablating apparatus (e.g. the electrode mechanism 20,22) isstructured to cause thermal cutting or ablating of tissue and theprotector 24 is structured to isolate or protect adjacent tissue locatedadjacent the second side of the protector 24. For example, the protector24 may be formed partially or entirely of an insulating material.Alternatively or additionally, the protector 24 may be formed of metaland include a coating 30 made of an insulating material, such as apolymer, for example, a polyimide material.

Turning back now to FIG. 1, the cutting or ablating device 10 may beused as part of a surgical system 11. The system 11 may comprise orconsist of a surgical control console 70 including a high frequencyelectrosurgical generator module 76 and an aspiration pump module 74. Asource of irrigation fluid 72 may also be provided which preferablyoperates as a gravity feed irrigation line. Control of the console 70during surgical procedures may be accomplished by use of an aspirationfootpedal 78 which controls an aspiration pump 74, and use of anelectrosurgical footpedal 80 which controls the electrosurgicalgenerator 76. One or both of the footpedals 78 and 80 may be pressuresensitive such that operating power is controllable by the depth ordistance at which the footpedal is pressed or moved by the operator.Furthermore, footpedals 78 and 80 may be combined into a singlefunctional unit. The cutting or ablation device 10 may be provided as apre-sterilized, single-use disposable probe that is attachable to astandard surgical handpiece. After the cutting and ablation device hasbeen attached to the handpiece, further connections to theelectrosurgical generator module 76, the aspiration pump module 74 andthe source of irrigation fluid 72, may be implemented as shown. Thus,the cutting or ablation device 10 has irrigation, aspiration, andelectrosurgical capabilities, as described herein.

A surgical procedure using the device 10 of the present invention may beperformed as follows.

Method for Performing Goniectomy

The device 10 and system 11 are useable to perform a variety ofprocedures wherein it is desired to form an incision or opening of adesired width or to remove, from a mass of tissue, a strip of tissue ofa desired width.

FIGS. 4A-4C, show an example of a goniectomy procedure that may beperformed to treat glaucoma, using the device 10 and system 11 of thepresent invention. This goniectomy procedure is an ab interno surgicalprocedure wherein a sector of the trabecular meshwork TM is removed fromthe eye of the patient to facilitate drainage of aqueous humor from theanterior chamber AC of the eye through Shlemm's Canal and the associatedcollector channels CC, thereby relieving elevated intraocular pressure.

First, a small incision IN is made in the cornea C at about 3 o'clock inthe left eye, or at about 9 o'clock in the right eye. A 1.5 mm slitknife may be used to make this incision IN.

The device 10 is attached to the source of irrigation fluid 72 (e.g.,balanced salt solution) such that irrigation fluid will flow throughlumen 16 of the outer tube 12 and out of outflow aperture 26. The device10 is then inserted through the incision IN and into the anteriorchamber AC (with irrigation flowing). In some cases, during theinsertion of the device 10, the source of irrigation fluid 72 mayinitially connected to the device such that the irrigation fluid willflow through the lumen 19 of the distal portion of inner tube 14. Inthis manner, irrigation fluid will begin to infuse into the anteriorchamber AC as soon as the distal tip of the protruding distal portion ofinner tube 14 has entered the anterior chamber AC, rather than beingdelayed until the larger outer tube 12 and aperture 26 have beenadvanced through the incision IN and into the anterior chamber. By thisalternative approach, irrigation fluid may be caused to flow out of theincision IN as the device 10 is being inserted, thereby spreading oropening the incision. Such spreading or opening of the incision IN mayfacilitate advancement of the larger diameter outer tube 12 through theincision IN. In cases where this alternative approach is used, thesource of infusion fluid 72 will be disconnected from lumen 19 after thedevice has been inserted into the anterior chamber AC and, thereafter,the infusion fluid source 72 will be reconnected to lumen 16 of outertube 12 such that infusion fluid will flow out of aperture 26. Negativepressure (e.g., via aspiration pump module 74) may then be applied tolumen 19 of the inner tube 14 so as to aspirate fluid and debris throughlumen 19. The vertical height of the infusion fluid source 72 may beadjusted to provide sufficient gravity feed of infusion fluid to make upfor the volume of fluid or matter being aspirated from the anteriorchamber AC through lumen 19, thereby maintaining the desired pressure offluid within the anterior chamber AC during the procedure.

A lens device (e.g. Ocular Single Mirror Gonio, Model OSMG, OcularInstruments, Bellevue, Wash.) may be positioned on the anterior aspectof the eye to enable the physician to clearly visualize the angle Awhere the segment of trabecular meshwork TM is to be removed. Under suchvisualization, the device 10 is advanced until the distal tip of thecutter tube or inner tube 14 is positioned adjacent to the trabecularmeshwork TM at the location where the strip is to be removed.Thereafter, the protector is advanced through the trabecular meshwork TMand into Schlemm's Canal SC.

The tissue cutting or ablation apparatus, such as bipolar electrodes 21,22 or 46, 47, is/are then energized and the device 10 is advanced alongSchlemm's Canal, thereby causing the cutting or ablation apparatus, suchas bipolar electrodes 21 and 22, to cut or ablate a strip of thetrabecular meshwork TM to create opening O, as shown in FIG. 4C.

In the bipolar embodiments of the device 10 shown in FIG. 2 or 5A-5B,discharge of electrosurgical energy via the bipolar electrodes 21, 22 or46, 47 will remove a full thickness strip of tissue from the trabecularmeshwork TM without traumatizing the underlying walls of Schlemm's canaland/or the collector channels, as those structures remain protected fromthe electrosurgical energy by the advancing protector 24 or 52. Theinsulated protector 24 or 52 serves two primary purposes: 1) the sizeand shape of the protector 24 or 52 allows its placement in Schlemm'sCanal SC to facilitate guiding the device along Schlemm's Canal SCduring the cutting of the strip from the trabecular meshwork TM and 2)the protector 24 or 52 protects and shields the underlying walls ofSchlemm's Canal SC and the collector channels from trauma duringelectrosurgical discharge.

After a strip of tissue of the desired length (e.g., about 2 mm to about10 mm) has been removed, the tissue cutting or ablation apparatus, suchas bipolar electrodes 21, 22 or 46, 47, is/are then de-energized, theaspiration and possibly infusion are stopped and the device 10 isremoved from the eye.

Following completion of the surgery, aqueous humor will drain from theanterior chamber AC through the opening O that was created by removal ofthe strip of tissue from the trabecular meshwork TM.

The present invention further provides a method for manufacturing adevice such as tube-fabricated device 10 shown in FIG. 2.

A method in accordance with the present invention for manufacturing thetube-fabricated device 10 generally comprises the steps of providingouter tube 12 and inner tube 14 made of suitable material, for examplehypotubing or other material suitable for use in ophthalmic surgery asdescribed elsewhere herein, and inserting the inner tube within thelumen 16 of the outer tube 12 such that a distal portion of inner tube14 extends or projects a sufficient distance beyond a distal end of theouter tube 12, as shown.

The method further comprises the steps of forming at least one leg on adistal portion of the inner tube 14, for example by beveling the distalend of the inner tube 14 and forming cuts therein and bending the atleast one leg to form the protector 24.

FIGS. 3A-3G show the steps involved in manufacturing the device 10 shownin FIG. 2, in accordance with one embodiment of the present invention.

Turning now to FIGS. 3A and 3A′, the step of forming at least one legcomprises cutting the distal portion of the inner tube 14, for example,having a beveled distal end of about 45 degrees, to form a first leg 24Aand a second leg 22A. The legs 22A and 24A may be formed by cuttingsubstantially U-shaped or V-shaped grooves or notches 28 into thebeveled distal portion of the inner tube 14 in order to form relativelylonger first leg 24A and a relatively shorter second leg 22A. In thisembodiment, the second leg 22A includes a narrow distal tip region and arelatively wider flared region proximal thereto.

The method may further comprise providing the cutting or ablatingapparatus of the device 10 adjacent the first side of the protector 24.More particularly, this step may comprise forming the electrodemechanism from a portion of the inner tube 14, for example, from thesecond leg 22A. For example, turning now to FIG. 3B, the final positionof the second leg 22A is pressed or bent radially inwardly as shown inFIG. 3B such that the distal most tip of the second leg 22A isappropriately positioned to form one pole of the bipolar electrodemechanism. In order to accommodate a second pole of the bipolarelectrode mechanism, the method may comprise forming an aperture 19 inthe second leg 22A, shown more clearly in FIG. 3B′ and passing a wire orother electrically conductive member 20 (hereinafter “electrode member20”) therethrough. The aperture 19 is cut to a size and configurationsuch that it will accommodate the electrode member 20 such as shown inFIG. 2.

The step of bending the second leg 22A may be accomplished by usingtweezers or other suitable tool for gripping and bending the second leg22A. The distal tip of the second leg 22A (which will form a pole of theelectrode) is positioned such that it is substantially aligned with acentral axis of the inner tube 14 in the final manufacturing process.

Next, the protector 24 (shown in FIG. 2) may be formed as follows.Second leg 22A is bent slightly radially outwardly, as shown in FIGS. 3Cand 30′. A forming member, for example a pin, wire or other preferablyrigid cylindrical member (shown in dashed lines in FIGS. 3C and 3D) isthen placed between the first leg 24A and second leg 22A.

Referring now to FIGS. 3D and 3D′, the first leg 24A is pressed, bent orotherwise shaped, for example by using substantially constant radialpressure, around the forming member, to form the curved configuration offirst leg 24A shown in FIG. 3D.

Protector 24, shown in FIGS. 3E and 3E′ may be formed by insulating thebent first leg 24A with insulating coating 30. This step may beaccomplished using any suitable means, for example, by dip coating,spray coating, or advancement of a fabricated cover over the first leg24A. The step of insulating or providing insulation may comprise dippingthe first leg 22A in a polymer precursor, for example a liquidpolyimide, and allowing the liquid polyimide to cure. In someembodiments of the invention, liquid polyimide is applied to both theinside, or first surface, and the outside, or second surface by using asuitable applicator, for example, a tip of a small diameter wire, forexample 0.006″ diameter wire dipped in a liquid polyimide. In any event,care is taken not to coat the distal tip of second leg 22A.

Turning now to FIGS. 3F and 3F′, the present invention may comprise thestep of forming first electrode 22, (hereinafter sometimes referred toas first pole of bipolar electrode) from distal portion of the innertube 14. This step may be accomplished by bending second leg 22Aradially inwardly, or in some circumstances, allowing second leg 22A torebound or spring back to its preformed, inwardly bent shape uponremoval of the cylindrical forming member (shown in dashed lines inFIGS. 3C and 3D).

As shown, in this particular embodiment, upon being bent inwardly, thedistal tip of the second leg 22A is positioned such that it is spacedapart from and adjacent the first side (inside surface) of the protector24 and is substantially aligned with the central axis of the inner tube14. The distal most tip of the second leg 22A forms the first pole ofthe bipolar electrode cutting mechanism.

Next, electrode member 20 is inserted or passed through aperture 19 asshown in FIG. 3G such that a distal tip of the electrode member 20 willform the second pole of the bipolar electrode. For example, the firstpole and the second pole of the bipolar electrode are preferably spacedapart from each other a distance of about 1/20 mm. The electrodes 21 and22 are operated to create high temperature region spanning/bridging theelectrodes 21 and 22, for example by formation of a high energy plasma.More specifically, the method of the invention may further include thestep of providing the electrode member 20 by stripping or removing adistal most portion of an insulated electrically conductive wire inorder to expose the conductive portion thereof which will form thesecond pole or second electrode 21 of the bipolar electrode mechanism.In other words, the electrically conductive member 20 may comprise aninsulated wire 20′ having insulation 23 stripped or removed from adistal tip thereof as shown in FIG. 2 and FIG. 3G, to expose theelectrically conductive tip. Alternatively, the method may compriseproviding a non-insulated electrically conductive wire and applyinginsulation to a proximal portion of the wire while leaving a distal mostportion exposed. Such insulation may be applied in a liquid form, forexample, the insulation may be applied as liquid polyimide, which isthen cured.

Once the second electrode 21 is appropriately placed, electricallyconductive member 20 is secured in place, for example by securing theelectrically conductive member 20 to the inner tube 14 for example, byadhesive or other suitable means.

The bipolar electrode and the first side of the protector 24 are spacedapart from each other a distance suitable to receive the tissue to becut by the device 10. It is noted that preferably, in this embodiment ofthe invention, the distal-most tip of the electrically conductive member20 is somewhat proximally located with respect to the distal-most tip ofthe second leg 22A in order to facilitate operation of the device, forexample to substantially prevent or reduce the occurrence of tissuebecoming unintentionally trapped or wedged within the device. Thisfeature of the invention is shown most clearly in FIG. 3G.

Turning now to FIG. 5A, an alternative distal end 40 of thetube-fabricated embodiment of the invention is shown, including outertube 42 and inner tube 44 that are similar or substantially identical toouter tube 12 and inner tube 14 described hereinabove with respect tothe device 10 shown in FIG. 2.

This alternative distal end may operate in is substantially the samefashion as the distal end of device 10 shown in FIG. 2. However, thealternative distal end is formed somewhat differently than the distalend shown in FIG. 2. As seen in FIGS. 5A and 5B, a distal portion of theprobe which becomes inserted into the anterior chamber of the eye has afrom side FS, A protector member 54 is located on the distal end of thatdistal portion. The protector member 54 has a first side 53, a secondside 52 and an end portion EP having a tip 55. The end portion EPprotrudes ahead of a straight line projected distally along the frontside FS of the distal portion of the probe, as indicated on FIG. 5B.Thus, the end portion EP is located distal to, and ahead of, the frontside FS of the distal portion of the probe. The first side 53 of the endportion EP slopes upwardly from the tip 55, forming an incline 57. Also,the end portion EP has a width W which tapers to its narrowest point atthe tip 55.

The differences may be more readily appreciated by comparing the distalend shown in FIG. 5B with the distal end shown in FIG. 3G. For example,it can be appreciated that second leg 46 (FIG. 5B) which may form afirst pole or first electrode of the electrode mechanism, is not bentradially inwardly like second leg 22 (FIG. 3G). In addition electricallyconductive member 45 may be positioned or disposed generally along acentral axis of the inner tube 44 rather than outwardly therefrom suchas electrically conductive member 20. The electrically conductive member45 includes second pole or second electrode 47 of the electrodemechanism.

As shown, electrically conductive member 45 may be held in place bymeans of bracket portions 49 formed from portions of second leg 46, asshown. The bracket portions 49 are preferably utilized for facilitatingpositioning of the electrically conductive member 45 during assembly.Adhesive and/or other means may be provided for securing theelectrically conductive member 45 in place.

As shown, outer tube 42 may define an irrigation lumen in fluidcommunication with irrigation port 48. Inner tube 44 may includeaspiration/irrigation lumen 50.

The invention has been described herein with reference to certainexamples and embodiments only. No effort has been made to exhaustivelydescribe all possible examples and embodiments of the invention. Indeed,those of skill in the art will appreciate that various additions,deletions, modifications and other changes may be made to theabove-described examples and embodiments, without departing from theintended spirit and scope of the invention as recited in the followingclaims. It is intended that all such additions, deletions, modificationsand other changes be included within the scope of the following claims.

What is claimed is:
 1. A device useable to sever a strip of trabecularmeshwork tissue from an eye, said device comprising: an elongate probehaving a front side, a rear side, and a distal portion that isconfigured for insertion into an anterior chamber of the eye; a memberat a distal end of the distal portion, said member having a first endportion which extends ahead of and distal to the front side of theelongate probe, said first end portion having a first side and a secondside, the first end portion having a width which tapers to its narrowestpoint at a tip of the first end portion and the first side of the firstend portion comprising an incline which slopes upwardly from the tip;said member having a second end portion which bends inwardly and formsan electrode of a bipolar ablation apparatus configured for ablating orcutting a strip of tissue; and; the device being further configured suchthat, the distal portion is insertable through a corneal incision andinto the anterior chamber and, thereafter, the member is advanceable,tip first, through the trabecular meshwork and into Schlemm's Canal suchthat the first side of the first end portion is positioned beneath thetrabecular meshwork, the elongate probe being thereafter moveable tocause tip-first advancement of the member through Schlemm's Canal withtrabecular meshwork tissue riding over the incline and into contact withthe bipolar ablation apparatus, thereby causing a strip of thetrabecular meshwork tissue to be cut by the bipolar ablation apparatus.2. A device according to claim 1 further comprising an irrigation lumen.3. A device according to claim 1 further comprising an aspiration lumen.4. A device according to claim 1 further comprising an irrigation lumenand an aspiration lumen.
 5. A device according to claim 1 wherein themember comprises a foot.
 6. A device according to claim 1 wherein thefirst end portion comprises a coating made of an insulating material. 7.A method for using a device according to claim 1, said method comprisingthe steps of: a) forming an incision in a cornea of an eye; b) insertingthe distal portion of the elongate probe through the corneal incisionand into an anterior chamber of the eye; c) advancing the distal portionacross an anterior chamber to a position where the member at the distalend of the distal portion is near trabecular meshwork tissue thatoverlies a Schlemm's Canal of the eye; d) advancing the member, tipfirst, through the trabecular meshwork tissue and to a position inSchlemm's Canal with the second side of the first end portion next to anouter wall of Schlemm's Canal and the first end portion of the memberbeneath the trabecular meshwork; and e) manually moving the probe toadvance the member, tip first, through Schlemm's Canal with trabecularmeshwork tissue passing over the incline and then into contact with thebipolar ablation apparatus, thereby causing a strip of the trabecularmeshwork tissue to be cut by the bipolar ablation apparatus.
 8. A methodaccording to claim 7 further comprising the step of retrieving the stripof trabecular meshwork tissue from the eye.
 9. A method according toclaim 7 further comprising the step of performing a chemical orbiological analysis on the strip of trabecular meshwork tissue.
 10. Amethod according to claim 7 wherein Step a comprises forming an openingthrough the cornea of the eye.
 11. A method according to claim 7 whereinStep a comprises forming an incision in the cornea at approximately athree o'clock position if in a left eye or at approximately a 9 o'clockposition if in a right eye.
 12. A method according to claim 7 whereinStep c comprises advancing the distal portion across a sagittal midlineof the anterior chamber to a position within the anterior chamber wherethe member at the distal end of the distal portion is near trabecularmeshwork tissue that overlies a Schlemm's Canal of the eye.
 13. A methodaccording to claim 7 wherein the device includes an irrigation lumen andwherein the method further comprises delivering an irrigation fluidthrough the irrigation lumen and into the anterior chamber.
 14. A methodaccording to claim 7 wherein the device includes an aspiration lumen andwherein the method further comprises aspirating fluid and/or matterthrough the aspiration lumen.